ID

42098

Description

Efficacy and Safety of LGX818 in Patients With Advanced or Metastatic BRAF V600 Mutant NSCLC; ODM derived from: https://clinicaltrials.gov/show/NCT02109653

Link

https://clinicaltrials.gov/show/NCT02109653

Keywords

  1. 9/28/15 9/28/15 - Julian Varghese
  2. 4/9/21 4/9/21 - Ahmed Rafee, MD
Copyright Holder

AR

Uploaded on

April 9, 2021

DOI

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License

Creative Commons BY 4.0

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Eligibility Non-Small Cell Lung Cancer NCT02109653

Eligibility Non-Small Cell Lung Cancer NCT02109653

Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
presence of braf v600e mutation in tumor tissue
Description

v600e mutation

Data type

boolean

Alias
UMLS CUI [1]
C3811884
histologically or cytologically confirmed diagnosis of stage iiib or iv nsclc
Description

stage iiib or iv nsclc

Data type

boolean

Alias
UMLS CUI [1]
C0278984
UMLS CUI [2]
C0278987
at least one measurable lesion as defined by recist v1.1
Description

measurable lesion as defined by recist

Data type

boolean

Alias
UMLS CUI [1,1]
C0221198
UMLS CUI [1,2]
C1513040
UMLS CUI [1,3]
C1709926
patients must have progressed during or after at least one previous systemic, anti-cancer treatment for locally advanced or metastatic nsclc.
Description

systemic, anti-cancer treatment; advanced or metastatic nsclc

Data type

boolean

Alias
UMLS CUI [1,1]
C1515119
UMLS CUI [1,2]
C0920425
eastern cooperative oncology group (ecog)/world health organization (who) performance status 0-2
Description

eastern cooperative oncology group; performance status

Data type

boolean

Alias
UMLS CUI [1]
C1520224
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
patients with symptomatic central nervous system (cns) metastases
Description

symptomatic central nervous system involvement; metastases; cns

Data type

boolean

Alias
UMLS CUI [1,1]
C0686377
UMLS CUI [1,2]
C0231220
history of leptomeningeal metastases
Description

leptomeningeal metastases

Data type

boolean

Alias
UMLS CUI [1]
C1704231
prior therapy with a braf inhibitor
Description

prior therapy

Data type

boolean

Alias
UMLS CUI [1]
C3838813
patients taking prohibited medication listed in the protocol
Description

medication; protocol

Data type

boolean

Alias
UMLS CUI [1]
C0525058
presence or history of a malignant disease other than nsclc that has been diagnosed and/or required therapy within the past 3 years.
Description

malignant disease other than nsclc

Data type

boolean

Alias
UMLS CUI [1]
C0006826
impaired cardiovascular function or clinically significant cardiovascular diseases
Description

significant cardiovascular diseases

Data type

boolean

Alias
UMLS CUI [1,1]
C0007222
UMLS CUI [1,2]
C0205082
pregnant or lactating women or woman of childbearing potential
Description

pregnant or lactating women of childbearing potential

Data type

boolean

Alias
UMLS CUI [1]
C0549206
UMLS CUI [2]
C2828358
UMLS CUI [3]
C3831118

Similar models

Eligibility Non-Small Cell Lung Cancer NCT02109653

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
v600e mutation
Item
presence of braf v600e mutation in tumor tissue
boolean
C3811884 (UMLS CUI [1])
stage iiib or iv nsclc
Item
histologically or cytologically confirmed diagnosis of stage iiib or iv nsclc
boolean
C0278984 (UMLS CUI [1])
C0278987 (UMLS CUI [2])
measurable lesion as defined by recist
Item
at least one measurable lesion as defined by recist v1.1
boolean
C0221198 (UMLS CUI [1,1])
C1513040 (UMLS CUI [1,2])
C1709926 (UMLS CUI [1,3])
systemic, anti-cancer treatment; advanced or metastatic nsclc
Item
patients must have progressed during or after at least one previous systemic, anti-cancer treatment for locally advanced or metastatic nsclc.
boolean
C1515119 (UMLS CUI [1,1])
C0920425 (UMLS CUI [1,2])
eastern cooperative oncology group; performance status
Item
eastern cooperative oncology group (ecog)/world health organization (who) performance status 0-2
boolean
C1520224 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
symptomatic central nervous system involvement; metastases; cns
Item
patients with symptomatic central nervous system (cns) metastases
boolean
C0686377 (UMLS CUI [1,1])
C0231220 (UMLS CUI [1,2])
leptomeningeal metastases
Item
history of leptomeningeal metastases
boolean
C1704231 (UMLS CUI [1])
prior therapy
Item
prior therapy with a braf inhibitor
boolean
C3838813 (UMLS CUI [1])
medication; protocol
Item
patients taking prohibited medication listed in the protocol
boolean
C0525058 (UMLS CUI [1])
malignant disease other than nsclc
Item
presence or history of a malignant disease other than nsclc that has been diagnosed and/or required therapy within the past 3 years.
boolean
C0006826 (UMLS CUI [1])
significant cardiovascular diseases
Item
impaired cardiovascular function or clinically significant cardiovascular diseases
boolean
C0007222 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
pregnant or lactating women of childbearing potential
Item
pregnant or lactating women or woman of childbearing potential
boolean
C0549206 (UMLS CUI [1])
C2828358 (UMLS CUI [2])
C3831118 (UMLS CUI [3])

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